Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPD



Status:Terminated
Conditions:Chronic Obstructive Pulmonary Disease
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 80
Updated:4/6/2019
Start Date:December 9, 2016
End Date:June 20, 2018

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A Randomized, Phase IIIb, Two-period , Double-blind, Two-treatment, Chronic-dosing (7 Days), Single-center Crossover Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease, Compared With Placebo

This is a randomized, double-blind, placebo-controlled, single-center, chronic-dosing (7
days), two-period, two-treatment, cross-over study to evaluate the treatment effect of PT003
compared with that of Placebo MDI on Cardiovascular Hemodynamics following chronic-dosing (7
days) in subjects with moderate to severe COPD.


Inclusion Criteria:

- At least 40 years of age and no older than 80 at Visit 1.

- Women of non-child bearing potential,or negative serum pregnancy test at Screening,
and agrees to acceptable contraceptive methods used consistently and correctly from
Screening until 14 days after final visit

- Evidence of lung hyperinflation

- Subjects with an established clinical history of COPD as defined by the American
Thoracic Society (ATS)/European Respiratory Society (ERS)

- Current or former smokers with a history of at least 10 pack-years of cigarette
smoking.

- Pre- and Post-bronchodilator FEV1/FVC ratio must be <0.70

- Post-bronchodilator FEV1 must be ≥30% to <65% predicted normal value, calculated using
NHANES III reference equations.

Exclusion Criteria:

- Significant diseases or conditions other than COPD which, in the opinion of the
Investigator, may put the patient at risk

- Women who are pregnant or lactating or are planning to become pregnant during the
course of the study

- Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma
or other active pulmonary disease

- Subjects who have been hospitalized due to poorly controlled COPD within 3 months
prior to Screening

- Subjects who have poorly controlled COPD, defined as acute worsening of COPD that
requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to
Screening or during the Screening Period

- Subjects who have clinically significant uncontrolled hypertension.

- Subjects with symptomatic prostatic hypertrophy that is clinically significant and not
adequately controlled with appropriate therapy, in the opinion of the Investigator.

- Subjects with bladder neck obstruction or urinary retention that is clinically
significant in the opinion of the Investigator.

- Subjects with a calculated creatinine clearance ≤30 mL/minute using Chronic Kidney
Disease Epidemiology Collaboration. (CKD-EPI) formula at Screening and on repeat
testing prior to Visit 2.

- Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥
1.5 times upper limit of normal at Screening and on repeat testing prior to Visit 2

- Subjects who have cancer that has not been in complete remission for at least five
years.

- Subjects with a diagnosis of glaucoma, who in the opinion of the Investigator, have
not been adequately treated.

- Subjects with a clinically significant ECG

- Subjects who were previously enrolled in any previous PT001, PT003, or PT005 study
conducted or sponsored by Pearl.
We found this trial at
3
sites
Birmingham, Alabama
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Denver, Colorado
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Philadelphia, Pennsylvania
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Philadelphia, PA
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